FDA Status

BioElectronics Comments on its U.S. FDA’s OTC Market Clearance Application

FREDERICK, Md., Oct. 10, 2016 /PRNewswire/ — BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced disposable electroceutical devices, announced that on Monday, October 3rd, 2016 it met with senior management from the FDA’s Division of Neurological and Physical Medicine Devices, including the Deputy Division Director, the Acting Branch Chief of the Physical Medicine and Neurotherapeutic Devices Branch, the three reviewers for the ActiPatch® Musculoskeletal Pain Therapy 51O(k) premarket notification, and the assigned statistician, to discuss the data requirements to support a musculoskeletal pain indication for the device.

In the 51O(k) premarket notification for the ActiPatch® Musculoskeletal Pain Therapy, we included our osteoarthritis of the knee and plantar fasciitis clinical studies, along with an explanation of the device’s mechanism of action, to support the indication for musculoskeletal pain relief. The agency has requested clinical data from an additional anatomical application area.

We are prepared to provide real world evidence showing use of the ActiPatch® for treatment of chronic back pain from our large UK chronic pain registry. The Agency is assessing whether the registry data, along with the two well controlled clinical studies mentioned above, would be sufficient to support a musculoskeletal pain indication, and FDA has defined certain criteria that it considers relevant to this assessment; we are preparing to submit the relevant information for the agency’s review. The original UK Registry was published in Pain Management A UK registry study of the effectiveness of a new over-the-counter chronic pain therapy, Pain Manag. 2015 Nov; 5(6): 413-23,http://www.futuremedicine.com/doi/full/10.2217/PMT.15.35

We have data on 5,660 back pain users, further supported by new data from an Observational Study on 117 subjects who used the ActiPatch® therapy over a 6-month period.

“We are hopeful that the data will meet the Agency’s acceptance criteria and will expedite over-the-counter market clearance for musculoskeletal pain relief,” said Ian Rawe, Ph.D., Director of Clinical Research, BioElectronics Corporation.

“I am pleased the agency has completed this step in streamlining the regulatory requirements for making available to Americans, the same safe drug-free pain relief option enjoyed in other countries around the world,” said Andrew J. Whelan, President. Earlier this year, in response to our request for information regarding the regulatory status of ActiPatch®, the FDA confirmed that it falls within the classification regulation that is the subject of the reclassification. We believe that the reclassification will contribute to an efficient review of our submitted evidence in our 510(k) premarket notification. The reclassification to Class II includes a provision for the FDA’s evaluation of our request for over-the-counter market clearance.

The Company is confident that the need for a safe, effective, and affordable drug-free treatment for chronic pain, without the dangers of narcotic and non-steroidal anti-inflammatory drugs, will further encourage swift FDA action.

We are pleased to announce we have filed a 510K Premarket Notification for ActiPatch® Therapy with the US Food and Drug Administration.

As most of you know, the FDA has not yet published the reclassification for pulsed shortwave from Class III to Class II as proposed in February of 2013. The mechanism of action of our device is different from traditional devices. We have filed a request for clarification to determine if we should continue to use the pulsed shortwave classification of our devices clarified, we have decided not to wait. We do not foresee adjusting or resubmitting the application to accommodate a different FDA action.

“I am pleased with the strength of this filing and confident that it will satisfy the agency staff,” said Andrew J. Whelan, President and CEO. “We felt the overwhelming nature of our evidence, the solid legal and regulatory support from the law firm of Goodwin Proctor, and the American consumers’ dire need for safe pain relief warranted filing. Our request for over-the-counter market clearance is strengthened by three clinical trials on ActiPatch use in osteoarthritis knees, plantar fasciitis and post-operative pain, our explanation of the mechanism of action, the overwhelmingly positive results of the recently published United Kingdom and Ireland Registry assessment of 5,000+ users, our surveys of users published this week in Pain Management, and the sale of hundreds of thousands of devices.

The extreme need for an effective, safe treatment for pain without the dangers of narcotics should move the FDA to a prompt and positive action.